A primary interest in being able to detect a target of interest is to detect pathogens including viruses, bacteria, and compounds, which are able to cause discomfort or disease in human or animal populations. One area of particular interest is to have a diagnostic kit for detecting the avian influenza virus. Diagnostic tests take years to develop and optimize, are subjected to rigorous clinical trials and regulatory requirements and once manufactured are valid only during their designated shelf life. In the instance where a clinically significant variation in the target for such a test is predicted or shown to sporadically arise, heretofore, a separate test must be designed to specifically detect that variant, that is the strain. In light of the long development timeline and the inability to predict demand for such a test, commercial diagnostic manufacturers may be reluctant to undertake development regardless of the potential benefits to society.
A model for such variations is the avian strains of influenza type A (FluA). Should one of these avian strains develop virulence for transmission in the human population the public health consequence could be severe as was seen in the 1918 “Spanish Flu” global pandemic. However, the H5N1 strain of avian influenza first detected in Hong Kong in 1997 has not yet developed such virulence and has remained almost entirely in the avian population for 8 years. While development of a general test for influenza type A is easily justified as various strains circulate every year, development and manufacture of a test specific for any single strain, such as H5N1, encompasses significant risk as it may not arise within the shelf life of the test.
The proactive development of a stable variant-specific ancillary detection method for use with existing nondiscriminatory tests in the field that could be rapidly deployed in the event of an outbreak would minimize the risk associated with esoteric variant-specific test development are desirable and allow for greater public safety.